Journal of Clinical Medicine (Dec 2022)
Efficacy of Bromhexine versus Standard of Care in Reducing Viral Load in Patients with Mild-to-Moderate COVID-19 Disease Attended in Primary Care: A Randomized Open-Label Trial
- María Luz Vila Méndez,
- Carmen Antón Sanz,
- Alicia del Rocío Cárdenas García,
- Amparo Bravo Malo,
- Francisco Javier Torres Martínez,
- José María Martín Moros,
- María Real Torrijos,
- José Francisco Javier Vendrell Covisa,
- Olga Guzmán Sierra,
- Verónica Molina Barcena,
- Nuria Viejo Pinero,
- Carlos Fernández Díaz,
- Purificación Arroyo Burguillo,
- Ana María Blanco Gallego,
- Carmen Guirao Sánchez,
- Aránzazu Montilla Bernabé,
- María del Pilar Villanueva Morán,
- Salvador Juárez Antón,
- Ángela Fernández Rodríguez,
- María Ángeles Somoza Calvo,
- Ernesto Cerrada Cerrada,
- Gemma Pérez Mañas,
- Antonio Sánchez Calso,
- Frida Vallejo Somohano,
- Carmen Cauqui Díaz,
- Gloria Viñas Fernández,
- Jesús Molina París,
- Marina González Godoy,
- Gonzalo Lumbreras García,
- Javier Rosado Martín,
- Aida Rodríguez Hernández,
- Sara López Antúñez,
- Gabriel Vázquez Perfecto,
- María Concepción Marcello Andrés,
- Nieves Marina Puente García,
- Carmen Gil,
- Ana Martínez,
- Begoña Soler López
Affiliations
- María Luz Vila Méndez
- Centro de Salud Fronteras, 28850 Torrejón de Ardoz, Spain
- Carmen Antón Sanz
- Consultorio Alpedrete, 28430 Alpedrete, Spain
- Alicia del Rocío Cárdenas García
- Consultorio Alpedrete, 28430 Alpedrete, Spain
- Amparo Bravo Malo
- Centro de Salud Palma Norte, 28015 Madrid, Spain
- Francisco Javier Torres Martínez
- Centro de Salud Palma Norte, 28015 Madrid, Spain
- José María Martín Moros
- Centro de Salud María de Guzmán, 28805 Alcalá de Henares, Spain
- María Real Torrijos
- Centro de Salud María de Guzmán, 28805 Alcalá de Henares, Spain
- José Francisco Javier Vendrell Covisa
- Consultorio Brunete, 28690 Brunete, Spain
- Olga Guzmán Sierra
- Centro de Salud Villalba Estación, 28400 Collado Villalba, Spain
- Verónica Molina Barcena
- Centro de Salud Fronteras, 28850 Torrejón de Ardoz, Spain
- Nuria Viejo Pinero
- Centro de Salud Fronteras, 28850 Torrejón de Ardoz, Spain
- Carlos Fernández Díaz
- Centro de Salud Fronteras, 28850 Torrejón de Ardoz, Spain
- Purificación Arroyo Burguillo
- Consultorio Collado Mediano, 28450 Collado Mediano, Spain
- Ana María Blanco Gallego
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- Carmen Guirao Sánchez
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- Aránzazu Montilla Bernabé
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- María del Pilar Villanueva Morán
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- Salvador Juárez Antón
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- Ángela Fernández Rodríguez
- Centro de Salud Benita de Ávila, 28043 Madrid, Spain
- María Ángeles Somoza Calvo
- Consultorio de Moralzarzal-EAP Villalba Pueblo, 28411 Moralzarzal, Spain
- Ernesto Cerrada Cerrada
- Centro de Salud Francia, 28943 Fuenlabrada, Spain
- Gemma Pérez Mañas
- Centro de Salud Francia, 28943 Fuenlabrada, Spain
- Antonio Sánchez Calso
- Centro de Salud Galapagar, 28260 Galapagar, Spain
- Frida Vallejo Somohano
- Centro de Salud Galapagar, 28260 Galapagar, Spain
- Carmen Cauqui Díaz
- Centro de Salud Galapagar, 28260 Galapagar, Spain
- Gloria Viñas Fernández
- Centro de Salud Francia, 28943 Fuenlabrada, Spain
- Jesús Molina París
- Centro de Salud Francia, 28943 Fuenlabrada, Spain
- Marina González Godoy
- Centro de Salud Francia, 28943 Fuenlabrada, Spain
- Gonzalo Lumbreras García
- Consultorio de Moralzarzal-EAP Villalba Pueblo, 28411 Moralzarzal, Spain
- Javier Rosado Martín
- Centro de Salud Reina Victoria, 28003 Madrid, Spain
- Aida Rodríguez Hernández
- Centro de Salud Reina Victoria, 28003 Madrid, Spain
- Sara López Antúñez
- Centro de Salud Reina Victoria, 28003 Madrid, Spain
- Gabriel Vázquez Perfecto
- Centro de Salud Dos de Mayo, 28934 Móstoles, Spain
- María Concepción Marcello Andrés
- Centro de Salud Galapagar, 28260 Galapagar, Spain
- Nieves Marina Puente García
- Centro de Salud Galapagar, 28260 Galapagar, Spain
- Carmen Gil
- Centro de Investigaciones Biológicas “Margarita Salas” (CSIC), 28040 Madrid, Spain
- Ana Martínez
- Centro de Investigaciones Biológicas “Margarita Salas” (CSIC), 28040 Madrid, Spain
- Begoña Soler López
- E-C-BIO, S.L., Las Rozas, 28230 Madrid, Spain
- DOI
- https://doi.org/10.3390/jcm12010142
- Journal volume & issue
-
Vol. 12,
no. 1
p. 142
Abstract
A 28-day randomized open-label multicenter study was conducted to assess the efficacy of bromhexine plus standard of care (SOC) (n = 98) vs. SOC alone (n = 93) in 191 outpatients with mild-to-moderate COVID-19 in the primary health care setting. Bromhexine three daily doses of 10 mL (48 mg/day) were administered for seven days. The primary efficacy endpoint was the reduction of viral load estimated as the cycle thresholds (Ct) to detect ORF1ab, N Protein, and S Protein genes by RT-qPCR in saliva samples on day 4 as compared with baseline. Ct values of the three genes increased from baseline throughout days 4 to 14 (p < 0.001) but significant differences between the study groups were not found. Differences in the percentages of patients with low, medium, and high viral loads at 4, 7, and 14 days were not found either. In summary, treatment with bromhexine plus SCO was associated with a viral load reduction of ORF1ab, N Protein, and S Protein genes at day 4, which was not significantly different than similar viral load reductions observed with SOC alone. The present findings do not seem to favor the use of bromhexine as an antiviral in patients with COVID-19.
Keywords